Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage
biopharmaceutical company pursuing novel therapeutics for
nonalcoholic steatohepatitis (NASH), today provides a summary of
corporate updates and reports fourth quarter and full year 2023
financial results.
Bill Sibold, Chief Executive Officer of Madrigal, stated “As we
approach the March PDUFA date for resmetirom, we remain focused on
advancing key regulatory, operational and commercial activities in
preparation for a potential U.S. launch. Our goal is to establish
resmetirom as the foundational therapy for NASH with significant
fibrosis, a serious disease with significant unmet need that
represents a high burden to patients, their families and the
healthcare system.”
Recent Corporate Updates
- On February 28, 2024, the Company announced that Mardi Dier
will join Madrigal as Chief Financial Officer. Ms. Dier has spent
over 20 years in executive financial leadership roles in
biotechnology companies, with deep experience in operational and
strategic decision making, capital raising, financial planning and
accounting (FP&A), global supply chain management, investor
relations and business development. She has held CFO positions at
Portola Pharmaceuticals, Ultragenyx, and Acelyrin.
- Additional appointments were made to the Madrigal leadership
team since fourth quarter of 2023, including Carole Huntsman to
Chief Commercial Officer, Ronald Fillipo to Chief Information
Officer, Clint Wallace to Chief Human Resources Officer, Mark
Barrett to Chief Business Officer and Tina Ventura to Chief
Investor Relations Officer.
- On February 8, 2024, positive results from the 52-week pivotal
Phase 3 MAESTRO-NASH trial were published in the New England
Journal of Medicine, including detailed analyses that reinforce the
safety and efficacy profile of resmetirom. MAESTRO-NASH is a
multicenter, randomized, double-blind, placebo-controlled Phase 3
study of resmetirom in patients with liver biopsy-confirmed
NASH.
- Five Madrigal health economic abstracts were presented at the
NASH-TAG conference, which took place January 4-6, 2024 in Park
City, Utah. Abstracts highlighted the serious clinical burden of
uncontrolled NASH and identified opportunities to improve patient
care.
- New data from the pivotal Phase 3 MAESTRO-NASH trial
demonstrating broad treatment effects of resmetirom on noninvasive
measures of liver health were presented at the American Association
for the Study of Liver Disease (AASLD) Liver Meeting ®, which took
place November 10-14, 2023 in Boston. Multiple additional Madrigal
abstracts at the conference examined resmetirom safety and efficacy
in NASH with significant fibrosis and NASH with compensated
cirrhosis.
Financial Results for the Three and Twelve Months Ended
December 31, 2023
As of December 31, 2023, Madrigal had cash, cash equivalents and
marketable securities of $634.1 million, compared to $358.8 million
at December 31, 2022. The increase in cash and marketable
securities was primarily from proceeds from our October 2023 public
offering partially offset by funding of operations.
Operating expenses were $117.2 million and $380.5 million for
the three and twelve month periods ended December 31, 2023,
compared to $85.3 million and $293.6 million in the comparable
prior year periods.
Research and development expenses for the three and twelve month
periods ended December 31, 2023, were $70.6 million and $272.4
million, compared to $70.7 million and $245.4 million in the
comparable prior year periods. The increases are attributable
primarily to a scale up of manufacturing activities to prepare for
the launch of resmetirom as well as an increase in R&D
personnel.
General and administrative (G&A) expenses for the three and
twelve month periods ended December 31, 2023 were $46.5 million and
$108.1 million, compared to $14.6 million and $48.1 million in the
comparable prior year periods. The increases are attributable
primarily to commercial activities in preparation for the expected
approval and launch of resmetirom. We expect our G&A expenses
to further increase as we expand our operating activities
associated with the commercialization of resmetirom.
Interest income for the three and twelve month periods ended
December 31, 2023, was $9.0 million and $19.6 million, compared to
$1.1 million and $2.2 million in the comparable prior year periods.
The increases in interest income for the latest three and twelve
month periods were due primarily to a higher average principal
balance in our investment account as well as higher average
interest rate in 2023.
Interest expense for the three and twelve month periods ended
December 31, 2023 was $4.0 million and $12.7 million, compared to
$1.7 million and $4.0 million in the comparable prior year periods.
The increase in interest expense was as a result of the higher
outstanding principal balances during the period under the
company’s loan facility as well as higher average interest rate in
2023.
About NASH
Nonalcoholic steatohepatitis (NASH) is a more advanced form of
nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause
of liver-related mortality and an increasing burden on healthcare
systems globally. Additionally, patients with NASH, especially
those with more advanced metabolic risk factors (hypertension,
concomitant type 2 diabetes), are at increased risk for adverse
cardiovascular events and increased morbidity and mortality.
Once patients progress to NASH with significant fibrosis
(consistent with fibrosis stages 2 and 3), the risk of adverse
liver outcomes increases dramatically. NASH is rapidly becoming the
leading cause of liver transplantation in the U.S.
Madrigal estimates that approximately 1.5 million patients have
been diagnosed with NASH in the U.S., of which approximately
525,000 have NASH with significant fibrosis. Madrigal plans to
focus on approximately 315,000 diagnosed patients with NASH with
significant fibrosis under the care of the liver specialist
physicians during the launch of resmetirom.
There are currently no FDA-approved therapies available for the
treatment of NASH. NASH is also known as “metabolic
dysfunction-associated steatohepatitis (MASH)” following a change
in disease nomenclature introduced by hepatology medical societies
in 2023.
About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a
clinical-stage biopharmaceutical company pursuing novel
therapeutics for nonalcoholic steatohepatitis (NASH), a liver
disease with high unmet medical need. Madrigal’s lead candidate,
resmetirom, is a liver-directed oral therapy that is designed to
target key underlying causes of NASH. For more information, visit
www.madrigalpharma.com.
Forward Looking Statements
This communication includes “forward-looking statements” made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, that are based on Madrigal’s beliefs
and assumptions and on information currently available to it, but
are subject to factors beyond its control. Forward-looking
statements reflect management’s current knowledge, assumptions,
judgment and expectations regarding future performance or events.
Forward-looking statements include: all statements that are not
historical facts; statements referenced by forward-looking
statement identifiers, including the examples in the paragraph
below; estimates of patients diagnosed with NASH; the relationship
between NASH progression and adverse patient outcomes; the
estimated clinical burden of uncontrolled NASH; analyses for
patients with NASH with significant fibrosis concerning potential
progression to cirrhosis, decompensated cirrhosis, liver transplant
or death; cardiovascular risks, comorbidities and outcomes; health
economics assessments or projections; resmetirom’s potential to be
the first specialty therapy for NASH patients with significant
liver fibrosis; projections or objectives for obtaining accelerated
or full approval for resmetirom, including all statements
concerning potential clinical benefit to support accelerated
approval and/or potential accelerated approval; and statements or
references concerning - the potential efficacy and safety of
resmetirom for noncirrhotic NASH patients and cirrhotic NASH
patients, possible or assumed future results of operations and
expenses, business strategies and plans (including ex-US.
Launch/partnering plans), research and development activities, and
the timing and results associated with the future development of
resmetirom, the timing and completion of projected future clinical
milestone events, including enrollment, additional studies,
top-line data and open label projections, Madrigal’s primary and
key secondary study endpoints for resmetirom and the potential for
achieving such endpoints and projections, the potential to support
an additional indication for resmetirom in patients with
well-compensated NASH cirrhosis, optimal dosing levels for
resmetirom and projections regarding potential NASH or NAFLD and
potential patient benefits with resmetirom, including future NASH
resolution, safety, fibrosis treatment, cardiovascular effects,
lipid treatment, and/or biomarker effects with resmetirom, and
strategies, objectives and commercial opportunities, including
potential prospects or results.
Forward-looking statements can be identified by terms such as
“accelerate,” “achieve,” “allow,” “anticipates,” “appear,” “be,”
“believes,” “can,” “confidence,” “continue,” “could,”
“demonstrates,” ”design,” “estimates,” “expectation,” “expects,”
“forecasts,” “future,” “goal,” “help,” “hopeful,” “inform,”
inform,” “intended,” “intends,” “may,” “might,” “on track,”
“planned,” “planning,” “plans,” “positions,” “potential,” “powers,”
“predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,”
“will achieve,” “will be,” “would” or similar expressions and the
negatives of those terms.
Forward-looking statements are subject to a number of risks and
uncertainties including, but not limited to: the assumptions
underlying the forward-looking statements; risks of obtaining and
maintaining regulatory approvals, including, but not limited to,
potential regulatory delays or rejections; risks associated with
meeting the objectives of Madrigal’s clinical studies, including,
but not limited to Madrigal’s ability to achieve enrollment
objectives concerning patient numbers (including an adequate safety
database), outcomes objectives and/or timing objectives for
Madrigal’s studies; any delays or failures in enrollment, and the
occurrence of adverse safety events; risks related to the effects
of resmetirom’s mechanism of action; the achievement of enrollment
objectives concerning patient number, safety database and/or timing
for Madrigal’s studies; enrollment and trial conclusion
uncertainties; market demand for and acceptance of our products;
the potential inability to raise sufficient capital to fund ongoing
operations as currently planned or to obtain financings on terms
similar to those arranged in the past; the ability to service
indebtedness and otherwise comply with debt covenants; outcomes or
trends from competitive studies; future topline data timing or
results; our ability to prevent and/or mitigate cyber attacks,
unauthorized exfiltration of data or other security incidents; the
risks of achieving potential benefits in studies that includes
substantially more patients, and patients with different disease
states, than prior studies; the timing and outcomes of clinical
studies of resmetirom; the uncertainties inherent in clinical
testing; and uncertainties concerning analyses or assessments
outside of a controlled clinical trial. Undue reliance should not
be placed on forward-looking statements, which speak only as of the
date they are made. Madrigal undertakes no obligation to update any
forward-looking statements to reflect new information, events or
circumstances after the date they are made, or to reflect the
occurrence of unanticipated events. Please refer to Madrigal’s
submissions filed with the U.S. Securities and Exchange Commission,
or SEC, for more detailed information regarding these risks and
uncertainties and other factors that may cause actual results to
differ materially from those expressed or implied. Madrigal
specifically discusses these risks and uncertainties in greater
detail in the sections appearing in Part I, Item 1A of its Annual
Report on Form 10-K for the year ended December 31, 2023, filed
with the SEC on February 28, 2024, and as updated from time to time
by Madrigal’s other filings with the SEC.
Investor Contact Tina Ventura, Madrigal
Pharmaceuticals, Inc., IR@madrigalpharma.com
Media ContactChristopher Frates, Madrigal
Pharmaceuticals, Inc., media@madrigalpharma.com
(tables follow)
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Statements of
Operations |
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
Total revenues |
|
$ |
- |
|
$ |
- |
|
|
$ |
- |
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
70,640 |
|
|
70,742 |
|
|
|
272,350 |
|
|
245,441 |
|
General and administrative |
|
|
46,536 |
|
|
14,557 |
|
|
|
108,146 |
|
|
48,130 |
|
Total operating expenses |
|
|
117,176 |
|
|
85,299 |
|
|
|
380,496 |
|
|
293,571 |
|
Loss from operations |
|
|
(117,176 |
) |
|
(85,299 |
) |
|
|
(380,496 |
) |
|
(293,571 |
) |
Interest income, net |
|
|
8,953 |
|
|
1,076 |
|
|
|
19,578 |
|
|
2,185 |
|
Interest expense |
|
|
(3,971 |
) |
|
(1,682 |
) |
|
|
(12,712 |
) |
|
(3,964 |
) |
Net loss |
|
$ |
(112,194 |
) |
$ |
(85,905 |
) |
|
$ |
(373,630 |
) |
$ |
(295,350 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(5.68 |
) |
$ |
(4.98 |
) |
|
$ |
(19.99 |
) |
$ |
(17.23 |
) |
Basic and diluted weighted average number of common shares
outstanding |
|
|
19,760,842 |
|
|
17,237,517 |
|
|
|
18,687,774 |
|
|
17,137,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Madrigal Pharmaceuticals, Inc. |
Condensed Consolidated Balance Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
|
December 31, |
December 31, |
|
|
|
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
634,131 |
|
$ |
358,774 |
|
|
|
|
Other current assets |
|
|
3,150 |
|
|
2,595 |
|
|
|
|
Other non-current assets |
|
|
3,266 |
|
|
1,203 |
|
|
|
|
Total assets |
|
$ |
640,547 |
|
$ |
362,572 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity |
|
|
|
|
|
|
Current liabilities |
|
$ |
118,548 |
|
$ |
115,894 |
|
|
|
|
Long-term liabilities |
|
|
116,666 |
|
|
49,289 |
|
|
|
|
Stockholders’ equity |
|
|
405,333 |
|
|
197,389 |
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
640,547 |
|
$ |
362,572 |
|
|
|
|
Grafico Azioni Madrigal Pharmaceuticals (NASDAQ:MDGL)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Madrigal Pharmaceuticals (NASDAQ:MDGL)
Storico
Da Set 2023 a Set 2024